Cell Therapy With Bone Marrow Mononuclear Cells in Critical Leg Ischemia (CLI)

• Sponsor: University of Paris 5 - Rene Descartes (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00377897
• Collaborator: Assistance Publique - Hôpitaux de Paris (Other)
• Enrollment: 20
• Location: 1
• Duration (Months): 59
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This study will treat by cell therapy 20 patients with critical leg ischemia (CLI) not eligible for revascularization or angioplasty. It will use exactly the same protocol as published by Tateishi-Yuyama et al. (Lancet 2002), using bone-marrow mononuclear cells (BMMNC).

Condition or Disease	Intervention/Treatment	Phase
Critical Leg Ischemia	Procedure: cell therapy	Phase 1

Detailed Description

Patients will be included with CLI according to the TASC criteria. Under general anesthesia, 500 ml of bone marrow is harvested in both iliac crests. After isolation and concentration of the BMMNC in 30 ml, 40 injections of around 0.75 ml will be done in the gastrocnemius of the ischemic leg, within 3 hours after preparation of the cell therapy product.

Patients will then be followed-up every week during one month and then every month during one year.

This study was approved by the ethical committee of Paris-Broussais HEGP (France) and our french regulatory agency (AFSSAPS).

It began including patients in January 2005 and will last until December 2007.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Optimisation d'un Produit de thérapie Cellulaire Autologue Par Cellules mononucléées médullaires Dans l'ischémie Critique Des Membres inférieurs liée à l'athérosclérose
• Study Start Date: Jan 1, 2005
• Anticipated Primary Completion Date: Sep 1, 2008
• Anticipated Study Completion Date: Dec 1, 2009

Outcome Measures

Primary Outcome Measures

1. Ankle brachial index [6 months]

2. Healing [1 year]

3. Amputation rate [1 year]

Secondary Outcome Measures

1. TcPO2 [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age > 18

• Signature of informed consent

• Critical leg ischemia with ankle pressure < 70 mmHg

• Ischemic ulcer or gangrene

• No possibility of surgical revascularization

• No possibility of angioplasty

Exclusion Criteria:

• Cancer

• Suspicion of a cancer on X-Ray, mammography or elevated PSA

• Age < 18

• Life expectancy < 6 months

• Active retinopathy

• Angioplasty or surgical revascularization within 3 months

• Stoke within 3 months

• HIV + or HCV/HBC+

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emmerich	Paris		France	75015

Sponsors and Collaborators

• University of Paris 5 - Rene Descartes
• Assistance Publique - Hôpitaux de Paris

Investigators

• Principal Investigator: Joseph Emmerich, Assistance Publique - Hôpitaux de Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00377897
• Other Study ID Numbers: OPTIPEC
• First Posted: Sep 19, 2006
• Last Update Posted: Feb 16, 2009
• Last Verified: Feb 1, 2009

• Keywords provided by , ,: critical leg ischemia; PAD; cell therapy
• Additional relevant MeSH terms: Ischemia

Study Results

No Results Posted as of Feb 16, 2009